Trials Today

Thoraflex Hybrid and Relay Extension Post-Approval Study

Purpose

The goal of this observational study is to evaluate the Thoraflex Hybrid device alone and in combination with the RelayPro NBS stent-graft in the treatment of aortic disease affecting the aortic arch and descending aorta with or without involvement of the ascending aorta. Patients who undergo treatment with the Thoraflex Hybrid device with or without extension with a RelayPro NBS stent-graft will be eligible for enrolment and study activities and follow-up regime will follow standard care at each participating site. Participant involvement in the study will last for a total of 10 years from the point at which the Thoraflex Hybrid device is placed.

Conditions

Thoracic Diseases
Aortic Aneurysm
Aortic Dissection
Thoracic Aortic Aneurysm
Thoracic Aortic Dissection

Eligibility

Eligible Ages: Over 18 Years
Eligible Sex: All
Accepts Healthy Volunteers: No

Inclusion Criteria

Patient is aged 18 years or older on date of consent. Patient is willing and able to comply with all study procedures and visits. Patient or their next of kin (NOK)/legally designated representative (LDR) has given written informed consent to participate in the study. Patient will undergo treatment with a Thoraflex Hybrid device. If a patient requires an extension procedure due to the extent of aortic disease, a RelayPro NBS Stent-graft should be placed inside the distal end of the previously placed Thoraflex Hybrid device via a retrograde approach. This may be part of the same or a two-stage procedure.

Exclusion Criteria

Patient has any medical, social, or psychological problems that in the opinion of the investigator preclude them from receiving this treatment and the procedures and evaluations pre and post procedure.

Study Design

Phase
Study Type: Observational
Observational Model: Cohort
Time Perspective: Prospective